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| Name | Class |
|---|---|
| The Center for Applied Health Sciences, LLC | INDUSTRY |
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The objective of this trial is to determine the effects of citicoline on mood in healthy Men and Women compared to a placebo.
This study is a 4-week, randomized, double-blind, placebo-controlled trial of citicoline in healthy men and women. Cognitive assessments will be performed to determine whether citicoline administration improves mood, compared to placebo administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citicoline | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citicoline | Dietary Supplement | Oral |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Total Mood Disturbance (TMD) score on the Profile of Mood States second eddition-Adult short (POMS2) | To evaluate the effect of the Test Product (TP) on TMD on the POMS2 compared to a placebo | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | To evaluate the effect of the TP on PSQI compared to a placebo | 4 weeks |
| Perceived Stress Scale (PSS-10) | To evaluate the effect of the TP on PSS-10 compared to a placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | To assess the safety and tolerability of the TP in healthy participants: Reports of Adverse Events to determine number of participants with adverse events. | 0-4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tim Ziegenfuss, Ph.D., CSCS, FISSN | Contact | 519-341-3367 | tz@appliedhealthsciences.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Applied Health Sciences | Recruiting | Canfield | Ohio | 44406 | United States |
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| ID | Term |
|---|---|
| D003566 | Cytidine Diphosphate Choline |
| ID | Term |
|---|---|
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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There are 2 study groups, including one test product (TP) group and one placebo (PL) group. Healthy adult males and females who are 21 to 65 years of age (inclusive) at screening will be enrolled.
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The placebo will match the TP in physical and visual appearance and packaging and each participant's study product assignments will be associated with a unique code to prevent premature unblinding. Planned unblinding will occur following database lock, definition of study populations, and a blinded statistical analysis. Delegated unblinded site personnel will be responsible for study product accountability, reconciliation, and record maintenance (i.e., receipt, reconciliation, and final disposition records) throughout the course of the study. The investigator will have oversight in a blinded manner.
| Dietary Supplement |
Oral |
|
| 4 weeks |
| Serum Brain-Derived Neurotrophic Factor (BDNF) and Homovanilic Acid (HVA) | To evaluate the effect of the TP on serum BDNF and HVA compared to a placebo | 4 weeks |
| Profile of Mood States second eddition-Adult short (POMS2) subdomain scores | To evaluate the effect of the TP on POMS2 subdomain scores compared to a placebo | 4 weeks |
| D009930 |
| Organic Chemicals |
| D009861 | Onium Compounds |
| D003565 | Cytidine Diphosphate |
| D003597 | Cytosine Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |